Biomarker Analyses and Final Overall Survival Results From a Phase III, Randomized, Open-Label, First-Line Study of Gefitinib Versus Carboplatin/Paclitaxel in Clinically Selected Patients With Advanced Non–Small-Cell Lung Cancer in Asia (IPASS)

医学 吉非替尼 卡铂 危险系数 内科学 肿瘤科 生物标志物 肺癌 表皮生长因子受体 埃罗替尼 基因突变 比例危险模型 酪氨酸激酶抑制剂 无进展生存期 腺癌 紫杉醇 化疗 癌症 突变 置信区间 生物 顺铂 基因 生物化学
作者
Masahiro Fukuoka,Yi‐Long Wu,Sumitra Thongprasert,Patrapim Sunpaweravong,Swan-Swan Leong,Virote Sriuranpong,Tsu-Yi Chao,Kazuhiko Nakagawa,Da-Tong Chu,Nagahiro Saijo,Emma Duffield,Yuri Rukazenkov,Georgina Speake,Haiyi Jiang,Alison Armour,Ka‐Fai To,James Chih‐Hsin Yang,Tony Mok
出处
期刊:Journal of Clinical Oncology [Lippincott Williams & Wilkins]
卷期号:29 (21): 2866-2874 被引量:1522
标识
DOI:10.1200/jco.2010.33.4235
摘要

The results of the Iressa Pan-Asia Study (IPASS), which compared gefitinib and carboplatin/paclitaxel in previously untreated never-smokers and light ex-smokers with advanced pulmonary adenocarcinoma were published previously. This report presents overall survival (OS) and efficacy according to epidermal growth factor receptor (EGFR) biomarker status.In all, 1,217 patients were randomly assigned. Biomarkers analyzed were EGFR mutation (amplification mutation refractory system; 437 patients evaluable), EGFR gene copy number (fluorescent in situ hybridization; 406 patients evaluable), and EGFR protein expression (immunohistochemistry; 365 patients evaluable). OS analysis was performed at 78% maturity. A Cox proportional hazards model was used to assess biomarker status by randomly assigned treatment interactions for progression-free survival (PFS) and OS.OS (954 deaths) was similar for gefitinib and carboplatin/paclitaxel with no significant difference between treatments overall (hazard ratio [HR], 0.90; 95% CI, 0.79 to 1.02; P = .109) or in EGFR mutation-positive (HR, 1.00; 95% CI, 0.76 to 1.33; P = .990) or EGFR mutation-negative (HR, 1.18; 95% CI, 0.86 to 1.63; P = .309; treatment by EGFR mutation interaction P = .480) subgroups. A high proportion (64.3%) of EGFR mutation-positive patients randomly assigned to carboplatin/paclitaxel received subsequent EGFR tyrosine kinase inhibitors. PFS was significantly longer with gefitinib for patients whose tumors had both high EGFR gene copy number and EGFR mutation (HR, 0.48; 95% CI, 0.34 to 0.67) but significantly shorter when high EGFR gene copy number was not accompanied by EGFR mutation (HR, 3.85; 95% CI, 2.09 to 7.09).EGFR mutations are the strongest predictive biomarker for PFS and tumor response to first-line gefitinib versus carboplatin/paclitaxel. The predictive value of EGFR gene copy number was driven by coexisting EGFR mutation (post hoc analysis). Treatment-related differences observed for PFS in the EGFR mutation-positive subgroup were not apparent for OS. OS results were likely confounded by the high proportion of patients crossing over to the alternative treatment.
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